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Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools.

Placebo

Administered in addition to the weight management program.

Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools.

Participant Flow: Overall Study

NB32

Placebo

STARTED [1]

4456

4454

Treated [2]

4455

4450

COMPLETED [3]

4455

4450

NOT COMPLETED

1

4

Randomized but not dispensed study med

1

4

[1]

Represents number of participants randomized

[2]

Represents number of participants included in the ITT analysis

[3]

Completed indicates treated participants. Represents number of participants in the ITT analysis.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools.

Placebo

Administered in addition to the weight management program.

Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools.

Total

Total of all reporting groups

Baseline Measures

NB32

Placebo

Total

Overall Participants Analyzed [Units: Participants]

4455

4450

8905

Age [Units: Participants]Count of Participants

Participants Analyzed

4455

4450

8905

<=18 years

0 0.0%

0 0.0%

0 0.0%

Between 18 and 65 years

2973 66.7%

3053 68.6%

6026 67.7%

>=65 years

1482 33.3%

1397 31.4%

2879 32.3%

Age [Units: Years]Mean (Standard Deviation)

Participants Analyzed

4455

4450

8905

61.1 (7.27)

60.9 (7.38)

61.0 (7.33)

Sex: Female, Male [Units: Participants]Count of Participants

Participants Analyzed

4455

4450

8905

Female

2437 54.7%

2419 54.4%

4856 54.5%

Male

2018 45.3%

2031 45.6%

4049 45.5%

Ethnicity (NIH/OMB) [Units: Participants]Count of Participants

Participants Analyzed

4455

4450

8905

Hispanic or Latino

279 6.3%

291 6.5%

570 6.4%

Not Hispanic or Latino

4174 93.7%

4156 93.4%

8330 93.5%

Unknown or Not Reported

2 0.0%

3 0.1%

5 0.1%

Race (NIH/OMB) [1] [2] [Units: Participants]Count of Participants

Participants Analyzed

4455

4450

8905

American Indian or Alaska Native

11 0.2%

20 0.4%

31 0.3%

Asian

19 0.4%

27 0.6%

46 0.5%

Native Hawaiian or Other Pacific Islander

6 0.1%

6 0.1%

12 0.1%

Black or African American

656 14.7%

648 14.6%

1304 14.6%

White

3738 83.9%

3698 83.1%

7436 83.5%

More than one race

NA [1]

NA [1]

NA [2]

Unknown or Not Reported

25 0.6%

51 1.1%

76 0.9%

[1]

Selection of multiple race categories was not permissible by the participants. Participants advised to select the most appropriate category.

[2]

Total not calculated because data are not available (NA) in one or more arms.

Region of Enrollment [Units: Participants]Count of Participants

United States

Participants Analyzed

4455

4450

8905

United States

4455

4450

8905

Weight [Units: Kilogram]Mean (Standard Deviation)

Participants Analyzed

4455

4450

8905

105.6 (19.09)

106.3 (19.18)

106.0 (19.14)

Body Mass Index (BMI) [1] [Units: Kg/m^2]Mean (Standard Deviation)

Participants Analyzed

4452

4450

8902

37.2 (5.26)

37.4 (5.44)

37.3 (5.35)

[1]

BMI was calculated at the site. Data are missing for 3 participants for whom the site did not calculate BMI, although weight and height were measured.

Percentage of Participants With a Confirmed Occurrence of Major Adverse Cardiovascular Event (MACE) [ Time Frame: Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up ]

Percentage of Participants With a Confirmed Occurrence of Cardiovascular Death, Nonfatal Myocardial Infarction, Nonfatal Stroke, or Nonfatal Unstable Angina Requiring Hospitalization [ Time Frame: Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up ]

Percentage of Participants With a Confirmed Occurrence of Cardiovascular Death (Including Fatal Myocardial Infarction, Fatal Stroke) [ Time Frame: Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up ]

Percentage of Participants With a Confirmed Occurrence of Myocardial Infarction (Nonfatal or Fatal) [ Time Frame: Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up ]

Percentage of Participants With a Confirmed Occurrence of Stroke (Nonfatal or Fatal) [ Time Frame: Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up ]

Limitations of the study, such as early termination leading to small numbers of participants
analyzed and technical problems with measurement leading to unreliable or uninterpretable data

The study was terminated early. Outcome measures data is based on the 50% interim analysis, designated as the primary analysis. Safety data is based on all available data at the time of database lock, which occurred after the 50% interim analysis.

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is more than 60 days but less than
or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Restriction Description:
If not already published by Sponsor as part of a multi-center publication, 24 months after conclusion, abandonment or termination of the study or notification that there will be no such multi-center publication, PI may publish the results for PI's study center individually. Prior to such publication, PI must provide Sponsor with at least 90 days to review and comment on the proposed publication. Sponsor may delay publication for up to an additional 6-month period to file for patent protection.